An Open-label Randomized Clinical Study to Compare the Effects of a Nutritional Supplement versus Vitamin E on Fibroscan Score in Nonalcoholic Steatohepatitis (NASH) Patients

摘要

Background: Despite the benefit of lifestyle changes, there is no standard treatment for Fibrotic NASH. However the concept of reversibility of liver fibrosis and cirrhosis with various natural biologically active compounds and antioxidant micro-nutrients is not new. Aim: The aim of this study was to compare effectiveness of Viusid~(?) (a nutritional supplement) and Vitamin E in reducing steatosis and liver fibrosis score in patients with fibrotic NASH. Methods: 52 patients diagnosed with nondiabetic and noncirrhotic NASH on liver fibroscan were divided into 2 groups randomly and given Viusid~(?) 3 sachets daily to 25 patients or Vitamin E 800 IU daily to 27 patients along with a hypocaloric diet and exercise for 3 months. Results: After 3 months treatment with Viusid~(?), as compared with Vitamin E, was associated with a significant reduction of both mean steatosis score (CAP value reduces from 286±16.3 to 208±18.5 dB/m in Viusid~(?) group vs. from 278±14.4 to 253±12.1 dB/m in Vitamin E group; p<0.00001) and fibrosis score (E value reduces from 6.8±0.5 to 5.1±0.7 kPa in Viusid~(?) group vs. from 6.9±0.5 to 6.5±0.4 kPa in Vitamin E group; p 0.00001). Conclusions: Viusid~(?) was superior to Vitamin E in reducing steatosis & fibrosis score in nondiabetic and noncirrhotic NASH patients. However, further large scale trial is needed to better assess the value of Viusid~(?) for fibrotic NASH management.